Description and Brand Names

US Brand Name

Caprelsa

Descriptions

Vandetanib is used to treat medullary thyroid cancer that cannot be treated with surgery or that has already spread to different parts of the body.

This medicine is available only under a registered distribution program called Vandetanib REMS (Risk Evaluation and Mitigation Strategy) Program. You will be asked to sign a form before you take this medicine. This form tells you about the benefits and risks of using this medicine. Make sure you understand what is on the form before you sign it.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, vandetanib is used in certain patients with the following medical conditions:

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of vandetanib in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of vandetanib in the elderly.

Pregnancy

Information about this vandetanib-oral-route

Pregnancy Category

Explanation

All Trimesters

D

Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Amifampridine

Bepridil

Cisapride

Dronedarone

Fluconazole

Ketoconazole

Mesoridazine

Nelfinavir

Pimozide

Piperaquine

Posaconazole

Saquinavir

Sparfloxacin

Terfenadine

Thioridazine

Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alfuzosin

Amiodarone

Amitriptyline

Anagrelide

Apomorphine

Aprepitant

Aripiprazole

Arsenic Trioxide

Artemether

Asenapine

Astemizole

Atazanavir

Azithromycin

Bedaquiline

Buserelin

Carbamazepine

Ceritinib

Chloroquine

Chlorpromazine

Ciprofloxacin

Citalopram

Clarithromycin

Clomipramine

Clozapine

Cobicistat

Crizotinib

Cyclobenzaprine

Dabrafenib

Darunavir

Dasabuvir

Dasatinib

Degarelix

Delamanid

Desipramine

Deslorelin

Digoxin

Disopyramide

Dofetilide

Dolasetron

Domperidone

Donepezil

Doxepin

Droperidol

Ebastine

Enzalutamide

Eribulin

Erythromycin

Escitalopram

Eslicarbazepine Acetate

Famotidine

Felbamate

Fingolimod

Flecainide

Fluoxetine

Formoterol

Fosaprepitant

Foscarnet

Fosphenytoin

Galantamine

Gatifloxacin

Gemifloxacin

Gonadorelin

Goserelin

Granisetron

Halofantrine

Haloperidol

Histrelin

Hydroquinidine

Hydroxychloroquine

Ibutilide

Idelalisib

Iloperidone

Imipramine

Itraconazole

Ivabradine

Lapatinib

Leuprolide

Levofloxacin

Lumefantrine

Mefloquine

Metformin

Methadone

Metronidazole

Mifepristone

Mitotane

Mizolastine

Moxifloxacin

Nafarelin

Nilotinib

Norfloxacin

Octreotide

Ofloxacin

Olanzapine

Ombitasvir

Ondansetron

Paliperidone

Panobinostat

Paritaprevir

Paroxetine

Pasireotide

Pazopanib

Pentamidine

Perflutren Lipid Microsphere

Perphenazine

Phenobarbital

Phenytoin

Primidone

Probucol

Procainamide

Prochlorperazine

Promethazine

Propafenone

Protriptyline

Quetiapine

Quinidine

Quinine

Ranolazine

Rifabutin

Rifampin

Rifapentine

Rilpivirine

Risperidone

Ritonavir

Sertindole

Sevoflurane

Siltuximab

Sodium Phosphate

Sodium Phosphate, Dibasic

Sodium Phosphate, Monobasic

Solifenacin

Sorafenib

Sotalol

St John's Wort

Sunitinib

Tacrolimus

Tamoxifen

Telaprevir

Telavancin

Telithromycin

Tetrabenazine

Tizanidine

Tolterodine

Topotecan

Toremifene

Trazodone

Trimipramine

Triptorelin

Vardenafil

Vemurafenib

Venlafaxine

Vilanterol

Vinflunine

Voriconazole

Vorinostat

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Torsade de pointes (abnormal heart rhythm), history of—Should not be used in patients with these conditions.

Hypocalcemia (low calcium in the blood) or

Hypokalemia (low potassium in the blood) or

Hypomagnesemia (low magnesium in the blood)—Use with caution. May cause side effects to be worse.

Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take this medicine exactly as directed even if you feel well. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Swallow the tablet whole. Do not break, crush, or chew it. You may take the tablet with or without food.

If you have trouble swallowing the tablets:

Dissolve the tablet in a glass containing 2 ounces of non-carbonated water. Do not use any other liquid.

Stir the mixture for 10 minutes and swallow it right away.

Rinse the glass with an additional 4 ounces of non-carbonated water and swallow the mixture to make sure you get the full dose of this medicine.

This mixture may also be given through a nasogastric or gastrostomy tubes.

Be careful not to handle crushed or broken tablets. If you have contact with broken or crushed tablets, wash your hands or skin with soap and water immediately.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):

For the treatment of medullary thyroid cancer:

Adults—300 milligrams (mg) once a day.

Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of this medicine and it is less than 12 hours since your regular time, take it as soon as you can and take your next dose at the normal time. If you miss a dose and it is more than 12 hours since your regular time, skip the missed dose and take your next dose at the normal time. Do not use extra medicine to make up for a missed dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this medicine. Blood tests may also be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. You should continue to use birth control at least 4 months after you have stopped taking this medicine. However, if you think you have become pregnant while using the medicine, tell your doctor right away.

Contact your doctor right away if you have any changes in your heart rhythm. You might feel dizzy, faint, or have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.

Avoid overexposing your skin to sunlight. Always use sunscreen or sun-blocking lotions and wear protective clothing and hats while you are using this medicine and for 4 months after the last dose.

Call your doctor right away if you have unexplained shortness of breath, cough, and fever that comes on suddenly. These may be symptoms of a serious lung condition.

Stop using this medicine and call your doctor right away if you have confusion; difficulty with speaking; slow speech; an inability to speak; an inability to move your arms, legs, or facial muscles; double vision; or a headache. These may be symptoms of a stroke.

This medicine may increase your chance of bleeding. Tell your doctor right away if you have bleeding gums, coughing up blood, difficulty in breathing or swallowing, dizziness, headache, increased menstrual flow or vaginal bleeding, nosebleeds, prolonged bleeding from cuts, red or dark brown urine, red or black, tarry stools, or shortness of breath. To help with this problem, stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

If you are rapidly gaining weight, having shortness of breath, chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of heart problems or your body keeping too much water.

This medicine may cause diarrhea. This may also increase your risk of having an electrolyte imbalance (e.g., low potassium, magnesium, or calcium in the blood). Tell your doctor right away if you start having muscle cramps or twitching, mood or mental changes, or unusual tiredness or weakness while being treated with this medicine.

Check with your doctor if you have a headache, seizures, confusion, blurred vision or other visual problems. These may be symptoms of a rare and serious condition called reversible posterior leukoencephalopathy syndrome (RPLS).

Check with your doctor right away if blurred vision, difficulty with reading, eye pain or irritation, or any other vision change occurs during therapy. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may cause blurred vision. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to see well.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (St. John's wort) or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Abdominal or stomach cramps or pain

bleeding gums

blurred vision

body aches or pain

chest pain

cloudy urine

confusion

convulsions

cough

coughing up blood

difficulty with breathing or swallowing

dizziness

ear congestion

fainting

fever or chills

headache

increased menstrual flow or vaginal bleeding

irregular heartbeat recurrent

loss of voice

muscle cramps in the hands, arms, feet, legs, or face

nervousness

nosebleeds

numbness and tingling around the mouth, fingertips, or feet

paralysis

pounding in the ears

prolonged bleeding from cuts

red or black, tarry stools

red or dark brown urine

slow or fast heartbeat

sneezing

sore throat

stuffy or runny nose

tenderness

tightness in the chest

tremor

troubled breathing

unusual tiredness or weakness (severe)

watery or bloody diarrhea

Less common

Blue lips, fingernails, or skin

chest pain or discomfort

dilated neck veins

extreme fatigue

foreign substance into the lungs

infection from breathing

irregular breathing

irregular heartbeat

irregular, fast or slow, or shallow breathing

lightheadedness

no breathing

swelling of the face, fingers, feet, or lower legs

weight gain

Rare

Bloating

constipation

darkened urine

decreased urine output

indigestion

loss of appetite

nausea

pains in the stomach, side, or abdomen, possibly radiating to the back

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acid or sour stomach

belching

blemishes on the skin

blindness

blistering, crusting, irritation, itching, or reddening of the skin

change in taste

cracked, dry, or scaly skin

cracks in the skin

decreased appetite

decreased vision

decreased weight

depression

discoloration of the fingernails or toenails

dry mouth

dry skin

hair loss or thinning of the hair

heartburn

increased sensitivity of the skin to sunlight

itching skin

lack or loss of strength

loosening of the fingernails

loss of heat from the body

loss of taste

muscle aches or spasms

pimples

rash with flat lesions or small raised lesions on the skin

red, swollen skin

redness or other discoloration of the skin

redness or soreness around the fingernails

severe sunburn

stomach discomfort or upset

swelling

trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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